One can't help but note a strange correlation of the number of warning letters with the US election cycle: dramatic decrease in 2001-2 and pickup in 2009. A cynical person might conclude that there was a deregulatory period driven by politics.

Looks like more politics than actually trying to make some real difference.It would be interesting to know how much delay these procedural changes have made in time to market a device. And whether these process changes have actually brought in any values.

The FDA, being a govt agency, naturally ends up greasing the skids for big money medicine so that in a few years the recalls and lawsuits start coming. The days when lawsuits were a sufficient deterent are gone, since they are factored into the cost of doing business. So as much as tighter regulations are despised, they are needed. Although copying Europe outright might be a good idea if they have a better system.

How else do we balance raw market forces flooding the market with incompatible and unsafe products other than by some kind of legislation? We as consumers need protection, unless you think a 'devil take the hindmost' society represents the pinnacle of civilization? And if we don't apply and enforce standards in medical care, why bother anywhere else?

The regulation of medical devices is already a throttle for the innovation. The propsed changes by FDA will make it much more harder for the medical device manufacturers to get the agency approvals and to deliver the products into the market. The US companies trying to reaach the global market with their products may have to put in lot of effort to design the products when compared to the european counter parts.